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DECISION No. 66/2004/QD-BNN OF NOVEMBER 22, 2004 PROMULGATING THE REGULATION ON ACCREDITATION, MANAGEMENT AND SUPERVISION OF AGRICULTURAL CROP SEED TESTING LABORATORIES, SAMPLERS AND FIELD INSPECTORS

THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to the Government's Decree No. 86/2003/ND-CP of July 18, 2003 defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the National Assembly Standing Committee's December 24, 1999 Ordinance No. 18/1999/PL-UBTVQH10 on Goods Quality;

Pursuant to the XIth National Assembly Standing Committee's March 24, 2004 Ordinance No. 15/2004/PL-UBTVQH on Plant Varieties;

Pursuant to the Government's Decree No. 179/2004/ND-CP of October 21, 2004 providing for the State management over product and goods quality;

Pursuant to standard TCVN ISO/IEC 17025:2001 General requirements for the capacity of calibration and testing laboratories; standard 10 TCN 382-1999 General requirements for agricultural testing laboratories; and standard 10 TCN 322-2003 Method of testing agricultural crop seeds;

At the proposals of the directors of the Science and Technology Department and the Agriculture Department,

DECIDES:

Article 1.- To promulgate the Regulation on accreditation, management and supervision of agricultural crop seed testing laboratories, samplers and field inspectors.

Article 2.- This Regulation replaces the accreditation of crop seed testing laboratories in the Regulation on accreditation of agricultural testing laboratories under Decision No. 139/1999/QD-BNN/KHCN of October 11, 1999 of the Minister of Agriculture and Rural Development.

Article 3.- This Decision takes effect 15 days after its publication in the Official Gazette.

Article 4.- The director of the Ministry's Office, the director of the Science and Technology Department, the director of the Agriculture Department and the concerned organizations and individuals shall have to implement this Decision.

For the Minister of Agriculture and Rural Development

Vice Minister
BUI BA BONG

REGULATION ON ACCREDITATION, MANAGEMENT AND SUPERVISION OF AGRICULTURAL CROP SEED TESTING LABORATORIES, SAMPLERS AND FIELD INSPECTORS

(Promulgated together with Decision No. 66/2004/QD-BNN of November 22, 2004 of the Minister of Agriculture and Rural Development)

Article 1.- Scope of regulation and subjects of application

1. This Regulation provides for the accreditation, management and supervision of agricultural crop seed testing laboratories, samplers and field inspectors.

2. This Regulation applies to organizations and individuals involved in the accreditation, management and supervision of agricultural crop seed testing laboratories, samplers and field inspectors.

Article 2.- Interpretation of terms

In this Regulation, the following terms are construed as follows:

1. Seed Testing Laboratory (hereinafter referred to as testing laboratories) means testing laboratories meeting the requirements set forth in this Regulation and accredited to perform crop seed quality tests.

2. Level-I Seed Testing Laboratory (hereinafter referred to as level-I testing laboratories) means testing laboratories meeting the requirements for level-I testing laboratories set forth in this Regulation and accredited to provide crop seed lot quality testing services.

3. Level-II Seed Testing Laboratory (hereinafter referred to as level-II testing laboratories) means testing laboratories meeting the requirements for level-II laboratories set forth in this Regulation and accredited to provide crop seed lot quality testing services.

4. Seed sampling means the taking of a prescribed quantity of seeds representing a seed lot for testing the quality criteria of that seed lot.

5. Seed sampler (hereinafter called seed sampler) means a trained and experienced person who is accredited to take crop seed samples.

6. Field inspection means the process of examining the quality of crop seed lots right on the fields or gardens in order to determine the seed originality, hereditary purity and level of blending with seeds or varieties of other crops.

7. Field inspector means a trained and experienced person who is accredited to conduct the inspection of crop seeds.

8. Proficiency testing means the audit of testing activities of a testing laboratory by method of interlaboratory comparison.

9. Interlaboratory comparison means the organization, performance and audit of tests with identical or similar testing contents at two or more testing laboratories under the pre-determined conditions.

10. Supervision (monitoring) means the process of regular examination of professional activities and results of inspection, sampling and testing by field inspectors, seed samplers and seed testing laboratories.

11. Inspection means the inspection of compliance through observation and judgment accompanied with appropriate measurements, tests and comparisons.

12. Audit means a documented independent and systematic process of considering and assessing evidences in an objective manner in order to determine whether the set standards are satisified.

13. Auditor means a capable person who has been trained in the ISO 17025 quality system and granted an auditor's certificate.

14. Auditing team means two or more auditors jointly conducting an audit.

Article 3.- Conditions for accreditation of testing laboratories, seed samplers and field inspectors

1. Seed testing laboratories shall be accredited only when they meet the following conditions:

a) Having the function and task of inspecting the quality of crop seeds;

b) Having a quality management system up to standard ISO 17025;

c) Having capable managers and trained technical staff who possess crop seed testing certificates;

d) Having equipment suitable to the crop seed quality testing requirements;

e) Having environmental control equipment suitable to the crop seed testing requirements;

f) Having participated in the proficiency testing scheme and having got satisfactory results at least three times for tests applied for accreditation;

g) Having conducted for at least two years the crop seed tests applied for accreditation and having tested at least 500 samples.

The minimum requirements for accreditation of testing laboratories are included in Annex 7 to this Regulation (not printed herein).

2. Seed samplers shall be accredited only when they satisfy the following conditions:

a) Having been trained in crop seed sampling and granted the certificate thereof;

b) Having at least one year's experience in crop seed sampling;

c) Having made no mistakes and got no customers' complaints on the sampling process.

Article 4.- Dossiers of application for accreditation of testing laboratories, seed samplers and field inspectors

1. A dossier of application for accreditation of an agricultural crop seed testing laboratory comprises:

a) An application for accreditation (made according to a set form);

b) The quality manual of the testing laboratory;

c) The proficiency testing result;

d) The report on the capability and operation result of the testing laboratory (made according to a set form).

2. A dossier of application for accreditation of a seed sampler comprises:

a) An application for accreditation (made according to a set form);

b) The certificate of training in sampling;

c) The report on the result of the sampling process.

3. A dossier of application for accreditation of a field inspector comprises:

a) An application for accreditation (made according to a set form);

b) The certificate of training in crop seed inspection;

c) The report on the result of the inspection process.

Article 5.- Receipt and evaluation of dossiers

1. Testing laboratories wishing to be accredited shall submit their dossiers to the Science and Technology Department of the Ministry of Agriculture and Rural Development.

2. The Science and Technology Department shall receive and check the dossiers of application for accreditation of testing laboratories. Where a dossier is incomplete or erroneous, within 15 days after receiving the dossier, the Science and Technology Department shall notify the applying testing laboratory of the contents to be completed.

3. Seed samplers and field inspectors wishing to be accredited shall send their dossiers to the Agriculture Department of the Ministry of Agriculture and Rural Development.

4. The Agriculture Department shall receive and check the dossiers of application for accreditation of seed samplers or field inspectors. Where a dossier is incomplete or erroneous, within 15 days after receiving the dossier, the Agriculture Department shall notify the applying seed sampler or field inspector of the contents to be completed.

Article 6.- Audit and accreditation of new testing laboratories, re-accreditation and expansion of the accredited scope

1. Auditing:

a) The Science and Technology Department shall conduct the audit, propose the accreditation of new testing laboratories, re-accreditation and expansion of the accredited scope after receiving the valid dossiers.

b) The Ministry of Agriculture and Rural Development shall set up the council for audit of testing laboratories applying for accreditation. The director of the Science and Technology Department shall be the council's chairman assisting the Minister in considering and auditing new testing laboratories. The council shall consist of 7 to 9 members being auditors who have been trained in testing laboratory audit and representatives of the Science and Technology Department and the Agriculture Department.

c) Auditing contents: Auditing the level of satisfaction of a testing laboratory's conditions prescribed in Clause 1, Article 3 of this Regulation.

d) Auditing order, procedure and method:

- The council chairman appoints an auditing team (consisting of 2 or 3 auditors who have been trained in audit and granted the auditor's certificates) to directly audit the quality management system and technical operations at the testing laboratory and report the audit result to the council;

- The council examines the dossier and report of the auditing team; discuss publicly and audit by secret vote;

- The council makes a conclusion written record and send the audit result (made according to a set form) to the Science and Technology Department;

- For qualified testing laboratories, the Science and Technology Department shall complete the procedures of submission to the Minister of Agriculture and Rural Development for accreditation. Where a testing laboratory has some inappropriate points which can be rectified, the council shall make a list of such points and set the deadline for their rectification. The Science and Technology Department shall notify the council's audit result to the testing laboratory;

- The testing laboratory rectifies inappropriate points and sends the report thereon to the Science and Technology Department. On the basis of the rectification result report (with the auditors' opinions when necessary), the Science and Technology Department shall consider and submit it to the Minister of Agriculture and Rural Development for accreditation if the testing laboratory is qualified. In case of necessity, the Science and Technology Department shall request a re-audit to be conducted.

e) Testing laboratories applying for re-accreditation: On the basis of the comprehensive audit results in the accreditation terms of the testing laboratories and the annual supervision results, the Science and Technology Department shall coordinate with the Agriculture Department in considering and submitting to the Minister of Agriculture and Rural Development for accreditation if the laboratories are qualified. In case of necessity, the Science and Technology Department shall request a re-audit to be conducted in the order stated in Item d, Clause 1 of Article 6.

f) Testing laboratories applying for expansion of the accredited scope

The auditing order and procedures shall comply with Item d, Clause 1 of Article 6 in order to audit the level of satisfaction of the conditions for expansion of testing laboratories. On the basis of the reports and proposals of the auditing teams, the director of the Science and Technology Department shall consider and propose the Minister to accredit or propose the setting up of the auditing council when deeming it necessary.

2. Accreditation:

The Minister of Agriculture and Rural Development shall consider and issue decisions to accredit new testing laboratories, re-accredit or expand the accredited scope.

Article 7.- Audit and accreditation of seed samplers and field inspectors

1. Audit: The Agriculture Department shall audit the dossiers submitted by seed samplers or field inspectors according to the provisions of Clauses 2 and 3, Article 4 of this Regulation.

2. Accreditation: The director of the Agriculture Department shall issue decisions to accredit seed samplers and field inspectors and grant certificates thereto.

Article 8.- Validity duration of accreditation decisions

1. The validity duration of decisions to accredit testing laboratories, seed samplers or field inspectors is five years.

2. Three months before the expiry of the validity duration of the accreditation decisions, the testing laboratories, seed samplers or field inspectors must send written applications for re-accreditation.

Article 9.- Management and supervision of testing laboratories, seed samplers, field inspectors

1. The Agriculture Department shall coordinate with the Science and Technology Department in conducting the examination and supervision of the accredited testing laboratories.

a) Periodical examination: The Agriculture Department shall conduct comprehensive examination once within the validity duration (five years) of the accreditation decisions.

b) Irregular examination: The Agriculture Department shall conduct irregular examinations when necessary.

c) Regular supervision: Annually, for audit, the Agriculture Department shall conduct re-examinations of the tested samples on a random basis (1% of the samples when testing laboratories test over 1,000 samples a year, 2% when testing laboratories test between over 500 and 1,000 samples a year; 5% when testing laboratories test between over 200 and 500 samples a year; or 8 to 10% when testing laboratories test under 200 samples a year). The supervision results shall be reported to the Agriculture Department.

2. The Agriculture Department shall supervise seed samplers and field inspectors.

3. Each testing laboratory, seed sampler or field inspector shall be granted a separate code for identification and management. Such codes shall be indicated in the accreditation decisions.

Article 10.- Suspension, cancellation of the validity of accreditation decisions

1. Suspension of the validity of accreditation decisions in case of technical mistakes which are rectifiable and have not yet caused serious consequences:

a) The Science and Technology Department shall assume the prime responsibility for, and coordinate with the Agriculture Department in, submitting to the Minister of Agriculture and Rural Development for consideration and issuance of decisions to suspend partly or wholly the validity of the testing laboratory accreditation decisions.

b) The director of the Agriculture Department shall issue decisions to suspend the validity of the seed sampler or field inspector accreditation decisions.

c) The validity of accreditation decisions shall be considered for restoration when the mistakes are rectified.

2. Cancellation of the validity of accreditation decisions in case of mistakes which are irrectifiable or have caused serious consequences:

a) The Science and Technology Department shall assume the prime responsibility for, and coordinate with the Agriculture Department in, submitting to the Minister of Agriculture and Rural Development for consideration and issuance of decisions to cancel the validity of the testing laboratory accreditation decisions.

b) The director of the Agriculture Department shall issue decisions to cancel the validity of the seed sampler or field inspector accreditation decisions.

c) Organizations and individuals that have committed mistakes, thereby causing serious consequences, must take responsibility according to law provisions.

3. Grounds for suspension, cancellation of the validity of accreditation decisions

a) Mistakes indicated in the reports on proficiency testing results, examination and supervision results;

b) Written complaints filed by customers;

c) Proposals made by the auditing council set up by the Science and Technology Department in case of necessity.

Article 11.- Changes to be reported

1. Accredited testing laboratories must report to the Science and Technology Department and the Agriculture Department on changes related to the accredited contents (addresses, telephone numbers, fax numbers, e-mail addresses, key personnel, organization, major equipment, etc.) within 30 days after effecting such changes.

2. Accredited seed samplers and field inspectors must report to the Agriculture Department on changes related to the accredited contents (addresses, telephone numbers, fax numbers, e-mail addresses, expanded operation scope, etc) within 30 days after effecting such changes.

Article 12.- Complaints and settlement thereof

1. Organizations' and individuals' complaints related to the audit or accreditation of seed testing laboratories shall be addressed to the Science and Technology Department for consideration and settlement according to its competence.

2. Organizations' and individuals' complaints related to the audit, accreditation and supervision of seed samplers and field inspectors shall be addressed to the Agriculture Department for consideration and settlement according to its competence.

3. Complaints related to the testing, sampling or inspection results shall be addressed to the testing laboratories, seed samplers or field inspectors that have produced such results. If disagreeing with the replies of the testing laboratories, seed samplers or field inspectors, the complainants may further file their complaints with the Agriculture Department for consideration and settlement.

4. If the complainants disagree with the settlement opinions of the Science and Technology Department or the Agriculture Department, they may file their complaints with the Minister of Agriculture and Rural Development.

Article 13.- Costs

1. Accreditation cost shall be borne by the applying testing laboratories, seed samplers or field inspectors.

2. Costs incurred in the settlement of complaints shall be paid by the mistaken parties.

Article 14.- Responsibility assignment

1. The Science and Technology Department shall have the responsibility:

a) To conduct evaluation and audit, and submit to the Minister of Agriculture and Rural Development for accreditation, re-accreditation or expansion of the accredited scope of testing laboratories.

b) The Science and Technology Department shall assume the prime responsibility for, and coordinate with the Agriculture Department in, considering and proposing the Minister of Agriculture and Rural Development to suspend or cancel the validity of testing laboratory accreditation decisions.

2. The Agriculture Department shall have the responsibility:

a) To manage and supervise the accredited testing laboratories, seed samplers or field inspectors;

b) To coordinate with the Science and Technology Department in considering and proposing the Minister of Agriculture and Rural Development to suspend or cancel the validity of testing laboratory accreditation decisions.

c) To consider and issue seed sampler or field inspector accreditation decisions;

d) To suspend or cancel the validity of seed sampler or field inspector accreditation decisions;

e) To conduct training for, and grant certificates to, testing laboratory staff, seed samplers and field inspectors;

f) To implement the proficiency testing scheme for testing laboratories applying for accreditation;

g) To organize the technical supervision of the accredited testing laboratories, seed samplers and field inspectors.

3. Testing laboratories, seed samplers and field inspectors shall have the responsibility:

a) To regularly provide training within the testing laboratories.

b) Testing laboratory staff, seed samplers and field inspectors must regularly attend re-training according to the training plan of the Central Crop Seed Assaying and Testing Center.

c) To report on their activity results once every six months to the Central Crop Seed Assaying and Testing Center.

d) The field inspection records, sampling records and testing result cards shall be made according to set forms.

For the Minister of Agriculture and Rural Development

Vice Minister

BUI BA BONG